Biology & Biotechnology

Strengthening India’s Biosecurity Framework

Context: Rapid advances in biotechnology, synthetic biology, and dual-use research have heightened the risk of deliberate biological threats. This makes biosecurity - distinct from biosafety—a strategic national priority for India.

image 5

What is Biosecurity?

Biosecurity refers to the policies, practices, and institutional systems designed to prevent the intentional misuse of biological agents, toxins, or life-science technologies.

  • Scope: Human health, animal health, agriculture, and the environment
  • Includes: Laboratory security, surveillance, export controls, and response to deliberate outbreaks
  • Biosafety vs Biosecurity:
    • Biosafety → Prevents accidental release of pathogens
    • Biosecurity → Prevents intentional misuse of biological materials

Why India Needs a Stronger Biosecurity Framework

  • Demographic Vulnerability:
    With a population exceeding 1.4 billion and high urban density, even small outbreaks can escalate rapidly. The COVID-19 pandemic exposed stress points in hospital capacity and disease surveillance.
  • Agriculture & Livelihood Risks:
    About 42% of India’s workforce depends on agriculture. Deliberate attacks on crops or livestock could undermine food security and rural incomes.
  • Dual-Use Research Risks:
    According to the WHO, nearly 42% of high-risk laboratories globally lack adequate oversight to prevent diversion of legitimate research for harmful purposes.
  • Non-State Actor Threats:
    Terrorist misuse of biological toxins remains a concern, with alleged ricin-related cases reported in India.
  • Global Preparedness Gap:
    India ranked 66th in the Global Health Security Index (2023), indicating relatively weaker response and preparedness capacities.

India's Existing Biosecurity Framework

Institutional Architecture

  • Department of Biotechnology (DBT): Regulates biotechnology research and biocontainment
  • National Centre for Disease Control (NCDC): Disease surveillance and outbreak response
  • Animal & Plant Authorities: Monitor zoonotic and agricultural bio-risks

Legal Framework

  • Environment (Protection) Act, 1986: Regulation of GMOs
  • WMD Act, 2005: Criminalises biological weapons
  • Biosafety Rules, 1989 & rDNA Guidelines, 2017: Standards for recombinant DNA research

International Engagement

  • Biological Weapons Convention (BWC): Prohibits biological weapons
  • Australia Group: Export controls on dual-use biological materials

Key Challenges

  • Fragmented Governance: No single nodal authority for biosecurity
  • Outdated Laws: Limited coverage of synthetic biology and gene editing
  • Dual-Use Oversight Gaps: No mandatory assessment of misuse potential
  • One-Health Silos: Human, animal, and environmental surveillance remain disconnected, despite 70% of emerging diseases being zoonotic

Way Forward

  • Unified Authority: Establish a National Biosecurity Authority (similar to Australia’s Biosecurity Act model)
  • Legal Modernisation: Update laws to regulate synthetic biology and gene editing
  • One-Health Integration: Link human, animal, and environmental surveillance
  • DNA Order Screening: Mandate verification of gene-synthesis orders
  • Global Cooperation: Deepen coordination under the Australia Group

India’s Shift from GM to Genome-Edited Crops

Context: India’s genetically modified (GM) crop progress has remained stagnant since the approval of Bt cotton in 2006. However, genome-edited (GE) crops have advanced rapidly due to regulatory relaxation, indigenous scientific tools, and rising public acceptance. This marks a major policy and technological shift in India’s approach to agricultural biotechnology.

Understanding Gene Editing

Gene editing modifies native genes within a plant without inserting foreign DNA.
It uses two key components:

  • Protein “scissors” to cut DNA at a targeted site
  • Guide RNA to direct the scissors precisely

This method mimics natural mutations and is therefore seen as safer, faster, and more predictable than traditional genetic modification.

How Gene Editing Differs from GMOs

1. Foreign DNA vs Native DNA

  • GMOs introduce genes from other species (transgenic).
  • GE crops alter only the plant’s own genes; no foreign DNA is added.

2. Regulatory Burden

  • GMOs require extensive biosafety, environmental, and GEAC-level approvals.
  • GE crops undergo simpler clearance through Institutional Biosafety Committees (IBCs), provided no foreign DNA remains.

3. Technological Pathway

  • GMOs rely on gene insertion into random genome locations.
  • GE techniques like CRISPR–Cas9, Cas12a, and TnpB create precise, site-specific edits.

4. Market Landscape

  • GM technology is dominated by large multinational corporations.
  • Gene editing democratises innovation, enabling public research institutions and small biotech labs to develop new varieties.

India’s Progress in Genome-Edited (GE) Crops

Indian research institutions have developed multiple GE lines:

1. GE Rice

  • Samba Mahsuri (High Yield)
  • MTU-1010 (Alkalinity Tolerance)

2. GE Mustard

  • Low-pungency, canola-quality mustard developed through targeted gene edits.

3. Editing Tools in Use

  • CRISPR–Cas9: drought and salinity tolerance
  • CRISPR–Cas12a: editing Gn1a gene for spikelet proliferation and higher yields
  • TnpB Miniature Gene Editor: an indigenous, patent-free, low-cost precision tool

Why GE Crops Are Succeeding Faster in India

1. Simplified Regulation

  • GE crops bypass GEAC if proven free of foreign DNA, reducing delays and costs.

2. Higher Public Acceptance

  • Absence of external genes reduces the controversy associated with GMOs.

3. Lower R&D Costs

  • CRISPR-based edits are economical and accessible to Indian labs.

4. Indigenous Innovation

  • India’s TnpB-based editor reduces reliance on expensive foreign technologies.

5. Targeted Government Support

  • The government allocated ₹500 crore (2023–24) exclusively for GE crop research.

6. Export Benefits

  • Countries like Japan and Australia allow GE food imports without GM labelling, supporting India’s agri-export potential.

Key Regulatory Bodies

Genetic Engineering Appraisal Committee (GEAC)

  • Apex body under MoEFCC for environmental release of GM organisms.

Institutional Biosafety Committee (IBC)

  • Verifies that gene-edited crops contain no foreign DNA and ensures biosafety compliance under DBT norms.

Conclusion

India’s transition from GM to genome-edited crops marks a strategic evolution in agricultural biotechnology. With regulatory clarity, indigenous tools, and strong research momentum, GE crops offer the potential for higher yields, climate resilience, and reduced input costs—positioning India for the next phase of sustainable agricultural innovation.

Precision Biotherapeutics: India’s Push Toward Next-Gen Personalised Medicine

Context: The Department of Biotechnology (DBT) and BIRAC have placed Precision Biotherapeutics as a national priority under the BioE³ Policy (Bioeconomy for Emerging India Ecosystem). This signals India’s commitment to building capabilities in personalised, gene-based, targeted and molecular therapies — the future of advanced medicine.

What are Precision Biotherapeutics?

Precision biotherapeutics are personalised, molecular-profile-based medical interventions designed using genomics, proteomics, bioinformatics, gene editing, RNA technologies, engineered cells, biologics, and AI-driven drug design.

They represent a shift from the traditional, symptom-based approach to root-cause correction at the level of genes, cells, or molecular pathways.

image 17

Key Technology Pillars

  1. Genomic–Proteomic Profiling
    Identifies patient-specific mutations, biomarkers, and disease signatures enabling personalised drug design.
  2. Gene & Cell Editing Technologies
    Includes CRISPR/Cas9, CAR-T therapy, siRNA, and AAV (Adeno-Associated Virus) vectors for targeted or curative interventions.
  3. mRNA & Nucleic Acid Therapeutics
    Synthetic RNA can act as programmable instructions to produce missing or corrective proteins within cells.
  4. AI-Driven Drug Discovery
    Uses machine learning for molecular docking, target prediction, toxicity screening, and accelerated drug development.

Significance of Precision Biotherapeutics for India

1. Targeted Cure Potential

Unlike general drugs, precision therapies directly treat root-cause mutations.
Example: CRISPR-based thalassemia therapy (Casgevy) approved by the US FDA and UK regulators in 2023.

2. Addressing India’s NCD Burden

Nearly 65% of deaths in India are due to non-communicable diseases. Standard medicine often fails for complex cancers, rare diseases, cardiometabolic disorders; precision medicine provides accurate, personalised solutions.

3. India-Specific Genomic Needs

India’s extreme genetic diversity means therapies developed abroad may not work optimally. Indigenous precision platforms are essential for “India-specific genotype therapies.”

4. Economic & Innovation Opportunity

The global precision biotherapeutics market is projected to exceed USD 22 billion by 2027, creating opportunities for biotech startups, IP creation, clinical trials, and high-value manufacturing.

Challenges in India

  1. High Therapy Cost
    Global gene/cell therapies cost USD 0.5–2 million (e.g., Zolgensma: USD 2.1M), inaccessible to 99% of Indian households.
  2. Regulatory Gaps
    India still lacks a dedicated CDSCO approval pathway for gene, cell, RNA, and genome-edited products.
    Japan’s PMDA regenerative fast-track is a model India could emulate.
  3. Insufficient Manufacturing Capacity
    India has a shortage of GMP-grade viral vector and biologics facilities.
    China, in comparison, runs 800+ ongoing gene/cell therapy trials.
  4. Skill Shortage
    India has only a few trained clinical geneticists compared to 4,000+ medical geneticists in the US.
  5. Ethical & Data Governance Concerns
    India lacks a specific genomic data protection law for biobanks and large datasets like IndiGen and GenomeIndia.

Way Forward

  • Dedicated Regulatory Pathway:
    Establish a CDSCO Gene–Cell Therapy Division with accelerated approvals.
  • Biomanufacturing Expansion:
    Create viral-vector & biologics GMP hubs under PLI-Biopharma.
  • Genomic Data Governance:
    Enact a bio-banking and consent law, aligned with EU-GDPR norms.
  • Affordability & Insurance Models:
    Pilot PM-JAY risk pooling for high-cost therapies.
  • Talent Pipeline:
    Launch national fellowships in genomic medicine & AI-biotech; integrate DBT–IIT–AIIMS translational tracks.
image 18

What do SC guidelines say on DNA?

Context: The Supreme Court has issued uniform guidelines to ensure the integrity of DNA (deoxyribonucleic acid) samples in criminal cases. 

Relevance of the Topic: Prelims: Key facts about SC guidelines say on DNA; Applications of DNA profiling. 

Importance of DNA evidence in criminal cases: 

  • DNA is a molecule that encodes the genetic information in all living organisms. It can be obtained from biological materials, such as bone, blood, semen, saliva, hair, or skin.
  • Generally, when the DNA profile of a sample found at a crime scene matches the DNA profile of a suspect, it can be concluded that both samples have the same biological origin. However, it is not substantive evidence in criminal cases. 
image 46

What do SC guidelines say on DNA?

The SC in Kattavellai @ Devakar v. State of Tamil Nadu has issued four guidelines for cases where DNA evidence is involved. 

  • Collection and documentation: DNA samples must be collected with due care, appropriately packed and labelled (FIR number and date, sections and statutes involved, details of the investigating officer, police station). The document must include the signatures and designations of the medical professional present, investigating officer, and independent witnesses.
  • Transportation: The investigating officer must ensure that the samples reach the concerned Forensic Science Lab within 48 hours of collection. The reasons for delay (if any) must be recorded, and samples should be preserved.
  • Storage: No package shall be opened, altered, or resealed without express authorisation from the trial court.
  • Chain of Custody Register (logbook that tracks DNA sample till the case ends) must be maintained. The investigating officer is responsible for explaining any lapses in compliance.

Need to issue the directions:

  • Though some guidelines have been issued by various bodies, there is neither uniformity nor a common procedure to be followed by all investigating authorities.  
  • ‘Police’ and ‘Public Order’ are subjects mentioned in the State List of the Seventh Schedule of the Constitution, but the SC deemed it necessary to issue these guidelines to have uniformity of procedure.
  • Past rulings show that lapses in handling have led to DNA reports being rejected, making both proper collection and quality control essential. 
  • Unexplained delays in sending DNA samples to the Forensic Laboratory (FSL) can risk the possibility of sample contamination.  

Associated Court rulings: 

  • In Anil v. State of Maharashtra (2014): The SC observed that a DNA profile is valid and reliable, but this depends on quality control and procedure in the laboratory. 
  • Manoj v. State of Madhya Pradesh (2022): The SC rejected a DNA report on the ground that recovery was made from an open area and the likelihood of its contamination cannot be ruled out. The blood stains found on the articles were disintegrated, and the quantity was insufficient to run any classification test.
  • Rahul v. State of Delhi (2022): The DNA evidence was rejected because it remained in the Police Malkhana for two months and during such time, the possibility of tampering could not be ruled out.
  • Kattavellai @ Devakar v. State of Tamil Nadu (2025): The SC  stated that DNA evidence is in the nature of opinion evidence as envisaged under Section 45 of the Evidence Act. Like any other opinion evidence, its probative value varies from case to case. Therefore, DNA evidence must be proved scientifically and legally. 

The investigating agency needs to ensure that samples are collected properly, without contamination, and sent to the FSL without delay. 

Also Read: DNA Profling 

Aedes-borne Viral Diseases and their Control 

Context: Aedes-borne Viral Diseases (ABVD) that include Dengue, Zika, and Chikungunya hurt India’s productivity. Aedes aegypti mosquitoes bite during the day time. Mosquito control methods like outdoor fumigation are not that effective, which necessitates revised strategies against Aedes Mosquitoes. 

Relevance of the Topic: Prelims: Key facts about Aedes-borne Viral Diseases; Wolbachia Method. 

Aedes-borne Viral Diseases

1. Dengue: 

  • Viral illness caused by the dengue virus, an RNA virus.
  • Transmission: 
    • Bites of infected Aedes aegypti mosquitoes.
    • There is no evidence that dengue can be transmitted directly from person to person through casual contact, coughing/sneezing, or sexual contact.
    • Rare cases of vertical transmission (from mother to child during pregnancy or childbirth) have been reported, but this is not a common mode of spread.
  • Symptoms: Flu-like symptoms, including high fever, severe headache, joint and muscle pain, and rash. In severe cases, it can lead to life-threatening dengue haemorrhagic fever. 

2. Zika: 

  • Caused by Zika virus, an RNA virus. 
  • Transmission: Bites of infected Aedes aegypti mosquitoes. Can be transmitted from mother to foetus during pregnancy; through sexual contact, blood transfusion; organ transplantation.
  • Zika infection during pregnancy causes microcephaly (underdeveloped brain) and other congenital malformations. 

3.  Chikungunya:

  • Caused by the chikungunya virus (CHIKV), an RNA virus.
  • Transmission: Bites of infected Aedes aegypti mosquitoes. An infected person cannot spread the infection directly to other persons (i.e. it is not a contagious disease).
  • Symptoms: Fever, chills, headache, nausea, vomiting, joint pain, and rash. Severe joint pain (arthritis) which is the most common feature of the disease. 
  • Chikungunya is diagnosed by blood test (ELISA). 

Wolbachia Method for Mosquito Control

  • Wolbachia is a form of biological control method to reduce mosquito population. 
  • In this method, naturally occurring Wolbachia bacteria is introduced into male population by infecting insects in a laboratory, and then releasing them into the wild.
  • These Wolbachia-infected male mosquitoes mate with female mosquitoes (not infected with the same strain of Wolbachia). 
  • These bacteria are passed on to their offspring through the normal reproductive process, and their offspring are less likely to survive or reproduce. 
  • The method does not suppress mosquito populations or involve genetic modification, so it is safe for humans, animals and the environment. 
image 40

Challenges in controlling Mosquito population: 

  • Limitations of conventional methods: Aedes mosquito feeds indoors during the day, and at night under artificial light. Methods like outdoor fumigation, vaporisers, and bed nets are thus ineffective against it. Additionally, the mosquitoes have evolved to gain tolerance to these chemicals. 
  • Lack of Vaccines: Dengue vaccine trials are underway, but these offer no protection against Zika or chikungunya.
  • Expensive: High costs and weak institutional support limit the adoption of advanced mosquito control methods like Wolbachia. 
  • Increased plastic pollution: Plastic pollution is directly linked to the risk of ABVD transmission. Discarded plastics can collect water and act as mosquito breeding sites). 

Way Forward

  • Application of safe non-insecticides (topical repellents) on the skin. By releasing volatile compounds, these repellants impair the mosquito’s sense of smell, thus making human hosts essentially invisible to them.
    • E.g., Para-menthane-diol (PMD), derived from the essential oil of the lemon eucalyptus plant; Picaridin (derived from pepper plant)
  • Using materials coated with delayed-release transfluthrin. These spatial emanators, like jute sheets, provide 15-days of continued protection in living spaces. 
  • Local community actions to remove larval breeding sites of Aedes mosquitoes. Regular trash collection/flood management protects against ABVD.

Public Health Campaign in Delhi: 10 Weeks, 10 AM, 10 Minutes

  • Called the rule of 10, “10 Weeks, 10 AM, 10 Minutes,” it reinforces larval source reduction as the primary strategy. 
  • It encourages every residential welfare association to mobilise each household to set aside 10 minutes at 10 AM every Sunday for 10 weeks from September to November. 
  • The goal is to find and eliminate sources of stagnant water during this high-risk season.

Also Read: Malaria Elimination: Efforts & Challenges 

AdFalciVax: Recombinant Multistage Malaria Vaccine

Context: The Union government has granted licence to five firms for manufacturing and commercialisation of AdFalciVax, India’s first indigenous recombinant multistage malaria vaccine, developed by the Indian Council of Medical Research (ICMR) and its partners.

Relevance of the Topic: Prelims: Key facts about Malaria & Malaria vaccines. 

Malaria is a life-threatening disease caused by plasmodium parasites transmitted through the bites of infected female Anopheles mosquitoes. 

AdFalciVax: Indigenous Malaria Vaccine 

  • India’s first indigenous recombinant multistage malaria vaccine. 
  • Developed by: Regional Medical Research Centre (RMRC), Bhubaneswar under the ICMR.
  • The vaccine is designed to prevent Plasmodium falciparum infection in humans and also reduce community transmission of the parasite.
    • Plasmodium falciparum is the deadliest malaria parasite (responsible for the most lethal form of malaria) and difficult to control. 
image 33

AdFalciVax: Recombinant Multistage Malaria Vaccine

1. Recombinant Malaria Vaccine: 

  • AdFalciVax is a recombinant malaria vaccine (made using genetic engineering). The vaccine uses Lactococcus lactis (a genetically engineered food-grade bacterial host).
    • Pieces of DNA from the malaria parasite (Plasmodium) are inserted into Lactococcus lactis (a safe bacterium often used in dairy fermentation). 
    • This genetically engineered bacterium acts as a bio-factory to produce the malaria antigens.

2. Multistage Malaria Vaccine: 

  • Existing Malaria vaccines like RTS, S/AS01 and R21/Matrix-M are single-stage vaccines i.e., they target the pre-erythrocytic/sporozoite stage.
    • Sporozoite stage is the stage when an infected female mosquito injects sporozoites (infectious cells of Plasmodium parasites) in the skin of a mammalian host.
  • AdFalciVax is amultistage vaccine i.e., it targets the two key stages of the Pasmodium parasite’s life cycle:
    • pre-erythrocytic/sporozoite stage
    • erythrocytic / blood stage: when the parasite infects red blood cells. (Only a few sporozoites leave the skin and travel through the bloodstream to reach the liver).

AdFalciVax targets the parasite before it enters the bloodstream, thus stopping the infection at the transmission stage. Hence, AdFalciVax vaccine not only protects the vaccinated human from developing Malaria but also reduces community transmission. 

Advantages of AdFalciVax

Preclinical data suggest that AdFalciVax have advantages over existing single-stage vaccines.

  • Broader protection by targeting two vulnerable parasite stages. 
  • Affordable, stable, and scalable solution. 
  • Thermal stability: Vaccine remains effective for over 9 months at room temperature.
  • Lower risk of immune evasion and potential for better long-term immunity. 

Pre-clinical validation of the vaccine

  • The pre-clinical validation of the vaccine has been conducted in collaboration with ICMR-National Institute of Malaria Research and National Institute of Immunology (NII).

Need for the Vaccine

  • Reduce Malaria burden: Malaria remains one of the major public health problems in India. India carries 1.4% of the global malaria case burden, and accounted for 66% of cases in the Southeast Asia region.
  • Meet India’s target under National Health Mission: Annual Malaria Incidence to be less than 1 in 1000 individuals. 

The government aims to facilitate the commercialisation of the vaccine to prevent and minimise malaria transmission. 

Also Read: Malaria Elimination: Efforts & Challenges   

Sickle Cell Anaemia and the battle for Disability Justice

Context: In 2024, the Indian government issued revised guidelines under the Rights of Persons with Disabilities (RPWD) Act, 2016. These guidelines provide a framework for assessing the extent of disability of people with two copies of the sickle cell gene, or with both sickle cell and beta thalassaemia, or Hb D.

Relevance of the topic:

Prelims: Key facts about Sickle Cell Anaemia; Rights to Persons with Disabilities Act 2016.

Mains: Issues in the Rights of Persons with Disabilities (RPWD) Act, 2016.

The RPWD Act 2016 marked a step towards protecting the rights of persons with disabilities, and promoting their full inclusion in society. The law aligns with the UN Convention on the Rights of Persons with Disabilities and promises dignity, equality, and non-discrimination. 

About Rights to Persons with Disabilities Act, 2016

  • The Act defines persons with disabilities as a person with physical, intellectual, or sensory impairment which, in interaction with barriers, hinders his full and effective participation in society equally with others. 
  • Types of disabilities covered under the Act are increased from 7 to 21. It includes various physical and mental disabilities like acid attack victims, dwarfism and Autism Spectrum Disorder.
  • Persons with benchmark disabilities are entitled to free school education up to 18 years of age, reservations in higher educational institutions, development assistance programmes, and government employment.
  • Reservation: It mandates a 4% reservation in public employment and 5% reservation in educational institutions for PwD. 
  • The Act mandates both public and private institutions to make infrastructure accessible and provide ICT consumer products for PwD.

Sickle Cell Anaemia

  • It is an inherited or genetic blood disorder that affects haemoglobin, the protein in Red Blood Cells (RBCs) that carries oxygen to all parts of the body.
  • Healthy RBCs are soft and round. In SCD, the haemoglobin is abnormal, which causes the RBCs to become hard and sticky and look like a sickle.
  • These rigid, sticky cells die early and often get stuck in blood vessels, clogging the flow of blood. As a result, different parts of the body do not get the oxygen they need. This can cause pain and other serious health problems such as infection, acute chest syndrome and stroke. 
image 18

Treatment: 

  • It is a lifelong illness. The only cure comes in the form of gene therapy and stem cell transplants, however, both are costly and still in developmental stages. 
  • Sickle Cell Anaemia Elimination Mission (2023) aims to eliminate sickle cell disease as a public health problem by 2047. 

Sickle cell disease (SCD) is a painful, progressive, and disabling blood disorder, disproportionately affecting marginalised communities like Tribals. 

Narrow lens of disability in Rights of Persons with Disabilities Act 2016

  • Not-inclusive: The Act extends reservations in public sector employment under the 4% quota for persons with vision and hearing loss, locomotor disabilities, and intellectual disabilities.  However, individuals with SCD and other blood disorders are not included in the quota.
  • Subjectivity in benchmark disability: The benchmark disability under the Act must meet a certain threshold of impairment, specifically 40% or more. However, different hospitals, medical boards, and doctors can assign different disability percentages to the same person, depending on their personal judgment.
  • Certification bottlenecks: A medical authority, including chief medical officer, evaluates and certifies disability. Diagnosis reports of confirmatory tests must be from a government or standard lab. The certification process can be largely inaccessible for Adivasi and Dalit patients in rural or remote areas. 

Way Forward

  • Extending job reservations to individuals with SCD and related blood disorders would acknowledge their condition as a significant, lifelong disability. 
  • Reforming the certification process to account for fluctuating and invisible disabilities would reflect a rights-based lens rather than a purely biomedical one.
  • Improve Accessibility: Mobile medical units in tribal and rural areas for on-site certification and treatment.

Disability is not only shaped by physical health, but also by social exclusion, structural barriers, and policy gaps. The continual reliance on biomedical scoring and exclusion of people with SCD from full protections undermines the very purpose of recognising the condition under the Act. 

Unless India’s recognition of SCD brings real rights and protections, it risks becoming exclusion disguised as inclusion. 

Also Read: The Rights of Persons with Disabilities Act, 2016 remains only a legal document without intense sensitisation of government functionaries and citizens regarding disability. Comment. 

Animal-Free Protein using Recombinant DNA Technology

Context: The global market base for alternative proteins is on the rise. Animal-Free Proteins produced using Recombinant DNA Technology are one such viable option to produce alternative proteins. 

Relevance of the Topic:Prelims & Mains: Recombinant DNA Technology: About, Applications & Benefits; BioE3 Policy.  

Animal-Free Protein using Recombinant DNA Technology: 

  • Animal-free protein refers to proteins (dairy, egg, meat proteins, other biological products) produced without using animals. The proteins are produced by relying on microbes (bacteria, fungi, yeast) engineered through Recombinant DNA Technology (rDNA). E.g.,
    • Casein (milk protein) produced in labs without cows.
    • Insulin (earlier extracted from a pig’s pancreas) is now developed by bacteria.
    • Collagen (earlier extracted from animal bones) is now produced in labs. 
  • This is also called precision fermentation or microbial fermentation.

Key steps involved:

  • Identification of the gene responsible for making a specific animal protein (E.g. Insulin)
  • Gene Insertion: The gene is inserted into the DNA of a vector (bacteria, fungi, yeast) using Recombinant DNA Technology. 
  • Protein Expression: The vector is now genetically engineered and acts like a mini factory (bio factory) and produces the desired protein. 

Benefits of Animal-Free Protein using Recombinant DNA Technology

  • Efficient: Requires less resources (land, water, feed) compared to traditional animal husbandry. 
  • Sustainable: Reduces dependence on livestock farming (which contributes to over 14% of global greenhouse gas emissions). 
  • Safer: Eliminates the risks of zoonotic pathogens (E.g., prions in mad cow disease, viruses in poultry). Reduced risk of xenobiotic rejection or allergic reactions. 
  • Animal Welfare: No ethical and moral issues.
  • Desired traits: Proteins can be modified for enhanced nutrition (E.g., more digestible Casein; allergen free proteins) 

What is Recombinant DNA Technology?

  • Recombinant DNA technology or genetic engineering involves manipulation of the genetic code or DNA of a living organism by combining genetic material from different sources.  
  • Basic principle: Isolating a specific gene or DNA sequence of interest from one organism and inserting it into the genome of another organism, via an appropriate vector. The inserted gene can be from the same species or from a different species.
  • Use case: It is used to obtain desired characteristics (traits) in living organisms or to produce useful biological products.  
image 18

Key steps involved in R-DNA technology: 

  • Isolation of the gene or DNA sequence of interest from the source organism.
  • Fragmenting this DNA using ‘molecular scissors’ (Restriction endonuclease Enzymes).
  • Screening the fragments for a ‘desired gene’.
  • Inserting the fragments with the desired gene into a ‘vector’ (plasmids, bacteriophage, cosmid) to develop a recombinant DNA (done using an enzyme called DNA ligase which acts like molecular glue).
  • Introducing the recombinant vector into the target organism or host cell. The vector integrates into the host's genome and the gene of interest is expressed. 
  • Expression: The target organism produces the protein encoded by the inserted gene.

Applications of R-DNA Technology: 

  • Creation of Genetically modified (GM) crops with desirable traits (resistance to pests, diseases, or herbicides). 
  • Production of therapeutic proteins such as insulin, interferon and human growth hormone (Human insulin was the 1st therapeutic protein to be genetically cloned in E.coli using R-DNA technology). 
  • Creation of Mono-clonal antibodies.
  • Production of vaccines. E.g., Hepatitis-B vaccine
  • Backbone of diagnostic tests for diseases like HIV and Hepatitis. 
  • Produce clotting factors for treating Haemophilia. 
  • Development of synthetic anti-venom, free from animal-derived proteins.
  • Create genetically engineered microorganisms for bioremediation and cleaning up environmental pollutants.

BIOE3 Policy: 

  • BioE3 (Biotechnology for Economy, Environment and Employment) policy was launched in 2024 by the Department of Biotechnology. 
  • Aim: Fostering high-performance biomanufacturing which involves the production of bio-based products across various sectors.
  • India's bio economy has skyrocketed from $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030. 
  • BioE3 Policy would focus on the following strategic and thematic sectors:
    • Smart proteins and functional foods
    • High value bio-based chemicals, biopolymers, and enzymes
    • Precision biotherapeutics
    • Climate resilient agriculture
    • Carbon capture & its utilisation
    • Marine and space research

Implementation Strategies:

  • Support innovation-driven research and development (R&D) and entrepreneurship.​
  • Establish biomanufacturing hubs, Bio-AI centers, and biofoundries.​
  • Expand India's skilled biotechnology workforce, especially in tier-II and tier-III cities.​
  • Align with initiatives like 'Net Zero' carbon economy and 'Lifestyle for Environment' (LiFE) to promote a circular bioeconomy.

With the launch of the BioE3 (Biotechnology for Economy, Environment, and Employment) policy, the government is focusing more on the manufacture of smart proteins, which entail reduced land, water, and energy requirements, while addressing nutritional needs and widespread protein deficiencies. 

Brain-eating Amoeba

Context: Kerala has reported a spike in the fatal primary amoebic meningoencephalitis (PAM) cases, caused by Naegleria fowleri (a brain-eating Amoeba), along with a few fatalities since the beginning of the year. 

Relevance of the Topic: Prelims: Key facts about Naegleria fowleri; Primary Amoebic Meningoencephalitis; Amoeba.

What is Naegleria fowleri?

  • Naegleria fowleri is a free-living amoeba or a single-celled living organism that causes a rare brain infection known as Primary Amoebic Meningoencephalitis (PAM).
  • It lives in warm fresh water and soil and infects people when it enters the body through the nose. It then travels up to the brain, where it causes swelling and destroys the brain tissue.
    • The amoeba can be found in warm freshwater, such as lakes and rivers, swimming pools, splash pads, surf parks, or other recreational venues that are poorly maintained or minimally chlorinated.
    • Higher temperatures of up to 115°F (46°C) are conducive to its growth and it can survive for short periods in warm environments. 
  • However, people cannot get infected with Naegleria fowleri from drinking water contaminated with the amoeba. PAM is also non-communicable. 
image 67

Primary Amoebic Meningoencephalitis (PEM):

  • Symptoms: In the initial stage, the symptoms include headache, fever, nausea and vomiting. Later on, the patient may have a stiff neck and experience confusion, seizures, hallucinations and slip into a state of coma.
  • Fatality: Most people with PAM die within 1 to 18 days after symptoms begin. It usually leads to coma and death after 5 days.
  • Treatment: No effective treatment for the disease has been identified yet. At present, it is treated with a combination of drugs, including amphotericin B, azithromycin, fluconazole, rifampin, miltefosine, and dexamethasone.
image 68

Facts about Amoeba: 

  • Amoebas are single-celled, eukaryotic organisms that belong to the kingdom Protista. They are found in a variety of aquatic and moist environments.
  • They have a simple, jelly-like body without a fixed shape. They move and feed by extending temporary projections called pseudopodia (false feet).
  • They reproduce asexually through binary fission where the cell divides into two identical daughter cells.
  • They are heterotrophic, meaning they obtain nutrients by engulfing and digesting organic matter, bacteria, and other microorganisms using their pseudopodia.
  • They have a simple internal structure, including a nucleus, vacuoles for osmoregulation, and various organelles for digestion and other cellular functions.
  • Some species of amoebas, such as Entamoeba histolytica, are parasitic and can cause diseases in humans, like amoebiasis.
  • Amoebas are important in aquatic food webs, serving as both predators and prey. They play a role in the cycling of nutrients in their ecosystems.

Vitamin D deficiency linked to Neurodevelopmental Issues

Context: A major study published in The Lancet Psychiatry has found a potential link between neonatal vitamin D levels and the risk of developing neurodevelopmental disorders such as schizophrenia, ADHD, and Autism.

Relevance of the Topic: Prelims: India’s Vitamin D Problem; Vitamin D. 

Vitamin D deficiency linked to Neurodevelopmental Issues

  • Researchers from Denmark used dried blood spot samples (Danish Neonatal Screening Biobank) from over 88,000 individuals born between 1981 and 2005.
  • From these samples, the team measured levels of:
    • 25-hydroxyvitamin D or 25(OH)D which is the standard marker of vitamin D status. 
    • Vitamin D-binding protein which carries vitamin D in the blood and prolongs its activity.
image 54

Key Findings of the Study:  

  • Babies with higher vitamin D levels were less likely to be diagnosed with schizophrenia, ADHD, or autism.
  • Newborns with levels about 12.6 nmol/l higher than average had an 18% lower risk of schizophrenia, an 11% lower risk of ADHD, and a 7% lower risk of autism. 
  • Vitamin D-binding protein levels were also linked to schizophrenia risk.
  • Researchers found no strong link between low vitamin D levels at birth (neonatal vitamin D) and the risk of depression or bipolar disorder later in life.

Limitations of the Study:  

  • Nearly all participants were of European Ancestry.
  • In a smaller non-European group, the results were less consistent, possibly due to lower vitamin D levels, smaller sample size, and/or genetic diversity. 
  • Gene variants may influence both vitamin D and neurodevelopment, a phenomenon known as pleiotropy. 
  • Vitamin D measured only at birth- the study could not pinpoint a critical window during pregnancy.

India’s Vitamin D Problem

  • India has a high Vitamin D deficiency rate despite abundant sunlight.
  • A study conducted at AIIMS Rishikesh between 2017 and 2018 found that 74% of infants and 85.5% of their mothers were deficient in vitamin D, with nearly half experiencing severe deficiency. 
  • A 2024 study conducted in the Bundelkhand region of India found a strong positive correlation between mothers’ and their infants’ vitamin D levels and interpreted it to mean babies born to vitamin D-deficient mothers were very likely to be deficient themselves.
  • However, findings also suggest that timely supplementation in deficient mothers can remarkably improve both maternal and neonatal levels.

Vitamin D insufficiency is not just an individual issue: it is a biological legacy passed from one generation to the next, shaping not just bones but brains too. India must move from reactive treatment to proactive care through awareness, screening, and timely supplementation.

How GLP-1 Drugs Work?

Context: Two GLP-1 drugs- Novo Nordisk’s semaglutide and Eli Lilly’s tirzepatide, are now available in the Indian market. 

Mounjaro, Ozempic, Wegovy, Semaglutide, Tirzepatide belong to a class of glucagon-like peptide-1 (GLP-1) receptor agonists, originally developed to treat diabetes and obesity.

Relevance of the Topic:Prelims: Key facts about GLP-1 Drugs. 

What are GLP-1 Drugs?

  • GLP-1 is an incretin hormone and a neurotransmitter naturally secreted from the small intestine and hindbrain in the human body, after one eats a meal. It travels to the pancreas, where it helps to regulate blood sugar by increasing insulin and decreasing glucagon.
  • GLP-1 RA (glucagon-like peptide-1 receptor agonists) are a new class of drugs that mimic naturally-occurring gut hormones called incretin (GLP-1 is one such incretin). Thus, they regulate appetite and digestion, helping users feel full faster and consume fewer calories.
  • Semaglutide and Tirzepatide both mimic the action of GLP-1. Tirzepatide additionally also mimics the action of another hormone called GIP (glucose-dependent insulinotropic polypeptide).

How GLP-1 Drugs Work?

GLP-1 drugs impact centres in the brain associated with control of hunger and satiety, to effectively tell us that we have had enough to eat and need to stop eating. They work by:

  • improving the secretion of insulin that allows more of the glucose in the bloodstream to enter cells where it can be used for energy. 
  • inhibiting the secretion of the hormone glucagon that stimulates the liver to release stored glucose into the bloodstream.
  • slowing down the emptying of the stomach so that the glucose levels in the bloodstream does not spike.  
  • reducing appetite by signalling to the brain that one is satiated.

The drugs can be self-administered by the patient once a week via subcutaneous injection (similar to insulin). Semaglutide is also available as an oral tablet. 

image 41

Utility of GLP-1 Drugs: 

  • Weight loss: Extremely effective for weight-loss helping people lose on an average 15% to 20% of their body weight, equivalent to otherwise lost with bariatric surgeries.
  • Diabetes: GLP-1 drugs infusion significantly increases insulin levels and lowers glucose levels in diabetic patients.
  • Alzheimer’s: Some evidence shows that the drugs are associated with lower risk of Alzheimer’s and Dementia.
  • Other Conditions: Found to be effective and are being studied for conditions including- cardiovascular diseases, kidney disease, non-alcoholic fatty liver disease, and obstructive sleep apnoea. Studies have shown a 69% reduction in heart failure events. 

Potential Side Effects of GLP-1 Drugs: 

  • Common side effects include- nausea, vomiting, acidity, burping, hiccups, diarrhoea, abdominal pain, and appetite loss. 
  • Rarer complications include- pancreatitis, retinal changes (necessitating eye exams), and increased risk of medullary thyroid carcinoma, especially for those with a family history.  

Confined field trials on Genetically Modified (GM) Maize

Context: Punjab Agricultural University (PAU) is set to begin confined field trials of genetically modified (GM) Maize in the ongoing kharif season. 

PAU has received approval from the Review Committee on Genetic Manipulation (RCGM), under the Department of Biotechnology, along with formal consent from the Punjab state government.

Relevance of the Topic: Prelims: Key facts about GM crops; GM Maize; Regulations related to GM crops. 

Confined Field Trials of GM Maize

  • PAU will conduct confined field-trials of two varieties of transgenic Maize in collaboration with Bayer Crop Science Limited (formerly Monsanto).
  • GM Maize has been genetically engineered with both herbicide-tolerant (HT) and insect-resistant Bacillus thuringiensis (BT) traits.
    • Herbicide-tolerant (HT) Maize: To study weed-control efficacy in herbicide-tolerant maize hybrids with the application of Glyphosate-K salt.
    • Insect-resistant (IR) Maize: To study the efficacy of insect-protected maize hybrids against targeted lepidopteran pests (stem borer; fall armyworm).
  • Confined field trials are small-scale field experiments to address the biosafety requirements and evaluate the performance of specific traits in genetically engineered plants.

Criticism of Confined field trials of GM Maize trials: 

Anti-GMO activists have expressed strong opposition to the project. The concerns include- 

  • Unintended environmental consequences including the risk of gene flow into nearby farms or wild varieties. Trials pose risks of genetic contamination and long-term ecological damage.
  • Risk of potential long-term health risks associated with GM food products.
  • Introduction of GM crops in India (even for research or confined trials) sets a dangerous precedent, particularly in Punjab where agricultural ecology is already under stress. Glyphosate-tolerant Maize trails are controversial as glyphosate (a herbicide) is currently banned in Punjab due to its negative impacts on human health and the environment.
  • Lack of transparency and insufficient public consultation. Bayer’s involvement has been questioned given the global controversies surrounding GM seed patent enforcement.

The organisations have demanded transparency on the scientific basis for the approval and raised concerns over biosafety violations in previous GM crop trials at PAU. 

PAU Maintains that:

  • Trials were permitted only after receiving clearance from the Government of India’s Review Committee on Genetic Manipulation (RCGM), under the Department of Biotechnology.
  • Biosafety Research Level 1 (BRL-I) trials (preliminary) and Advanced level II (BRL-II) trials would be carried out under strict standard operating procedures, with mandatory permission from state-level committees.

Review Committee on Genetic Manipulation (RCGM) is the regulatory authority for BRL-1 trials (size limited to no more than one acre/trial site location).

Genetic Engineering Appraisal Committee (GEAC) is the regulatory authority for Biosafety Research Level II (BRL- II) trials (size is generally limited to no more than 2.5 acres/trial site location).

What are GM Crops?

  • Genetically Modified (GM) crops are plants that have had their DNA modified (altered) through genetic engineering.
    • It involves inserting new DNA into the genome of a plant. 
    • The seeds produced by these plants will inherit the new DNA.
  • E.g., BT cotton is a genetically modified variety of cotton that contains genes from the bacterium Bacillus thuringiensis. 
image 40

Benefits of GM crops:

  • Genetic modification is done to transfer a particular trait to the plant in order to:
    • Increased the yield of a crop
    • Increased nutritional content of a crop
    • Developing resistance to:
      • Abiotic stresses like temperature, salinity or herbicide-resistant
      • Biotic stresses like insect-resistant crops.

Regulations related to GM crops: 

  • Genetically Modified Organisms (GMOs) and their products are regulated under the “Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/ Genetically Engineered Organisms or Cells, 1989.”
  • The rules are notified under the Environment (Protection) Act, 1986. These rules regulate the use, research, and commercialisation of GMOs, especially for environmental and biosafety concerns. 
  • The commercial cultivation and the field trials of GM crops require clearance from the Genetic Engineering Appraisal Committee (GEAC) under the Ministry of Environment, Forest and Climate Change. 
  • After the GEAC clearance, the state governments have the power to approve (or reject) the field trials of particular GM crops in their respective states.

Status of GM crops in India

  • BT cotton is the only GM crop that is commercially allowed for cultivation in India from 2002. 
  • Field trials of GM Mustard (DMH-11) were approved by GEAC in 2022, but its commercial release is still pending. 

Trending now

Balancing Security and Livelihoods: Punjab Border Fence Realignment
India’s Increasing Push for Free Trade Agreements
SHANTI Bill, 2025: Overhauling India’s Nuclear Energy Sector
Strengthening India’s Biosecurity Framework